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Tavalisse, Tavlesse(fostamatinib)
Tavalisse, Tavlesse (fostamatinib) is a small molecule pharmaceutical. Fostamatinib was first approved as Tavalisse on 2018-04-17. It is used to treat thrombocytopenia in the USA. It has been approved in Europe to treat thrombocytopenia.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
Trade Name
FDA
EMA
Tavalisse
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fostamatinib disodium
Tradename
Company
Number
Date
Products
TAVALISSERigel PharmaceuticalsN-209299 RX2018-04-17
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
tavalisseNew Drug Application2020-11-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
thrombocytopeniaHP_0001873D013921D69.6
Agency Specific
FDA
EMA
Expiration
Code
FOSTAMATINIB DISODIUM, TAVALISSE, RIGEL PHARMS INC
2025-04-17ODE-174
2023-04-17NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Fostamatinib Disodium, Tavalisse, Rigel Pharms Inc
87716482032-07-27DP
89515042032-07-27U-2294
82631222030-11-24DP
86524922028-11-06DP
74494582026-09-04DP
81639022026-06-17DPU-2294
84454852026-06-17DP
89121702026-06-17U-2294
92832382026-06-17U-2294
79894482026-06-12DPU-2294
75381082026-03-28DPU-2294
RE488982026-01-19DP
82118892026-01-19DP
92669122026-01-19U-2294
ATC Codes
B: Blood and blood forming organ drugs
B02: Antihemorrhagics
B02B: Vitamin k and other hemostatics
B02BX: Other systemic hemostatics in atc
B02BX09: Fostamatinib
HCPCS
No data
Clinical
Clinical Trials
58 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rheumatoid arthritisD001172EFO_0000685M06.979420
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.31438
Covid-19D000086382U07.11435
Hemolytic anemia autoimmuneD000744EFO_1001264D59.10123
PneumoniaD011014EFO_0003106J181112
Coronavirus infectionsD018352EFO_0007224B34.2222
Severe acute respiratory syndromeD045169EFO_0000694J12.8111
Viral pneumoniaD011024EFO_0007541J12.911
DiseaseD004194EFO_0000408R6911
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Iga glomerulonephritisD005922EFO_000419422
AnemiaD000740EFO_0004272D64.922
ThrombocytopeniaD013921HP_0001873D69.622
CoronavirusD017934111
Primary myelofibrosisD055728D47.411
Large b-cell lymphoma diffuseD016403C83.311
Renal cell carcinomaD00229211
Colorectal neoplasmsD01517911
Non-small-cell lung carcinomaD00228911
Head and neck neoplasmsD00625811
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients77
PharmacokineticsD01059944
Ovarian neoplasmsD010051EFO_0003893C5611
Hematologic neoplasmsD01933711
Drug interactionsD00434711
Renal insufficiencyD051437HP_0000083N1911
Hepatic insufficiencyD04855011
Biological availabilityD00168211
Myelodysplastic syndromesD009190D4611
Myelomonocytic leukemia chronicD015477C93.111
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFOSTAMATINIB
INNfostamatinib
Description
Fostamatinib, sold under the brand names Tavalisse and Tavlesse, is a tyrosine kinase inhibitor medication for the treatment of chronic immune thrombocytopenia (ITP). The drug is administered by mouth.
Classification
Small molecule
Drug classphosphoro-derivatives; tyrosine kinase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
COc1cc(Nc2ncc(F)c(Nc3ccc4c(n3)N(COP(=O)(O)O)C(=O)C(C)(C)O4)n2)cc(OC)c1OC
Identifiers
PDB
CAS-ID901119-35-5
RxCUI
ChEMBL IDCHEMBL2103830
ChEBI ID
PubChem CID11671467
DrugBankDB12010
UNII IDSQ8A3S5101 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Tavalisse - Rigel Pharmaceuticals
$
£
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,289 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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